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Sign in to claim this brandXinhua Healthcare Industry Co., Limited
US
Last updated May 23, 2026
What Xinhua Healthcare Industry Co., Limited makes
The company produces orthopaedic tools specifically designed for hip replacement surgery, including acetabular bone rasps and an acetabular file connecting rod. These devices are used to prepare the pelvic bone for the placement of acetabular components in total hip arthroplasty procedures.
The portfolio consists of Class I medical devices, which are regulated under the FDA’s Unique Device Identifier (UDI) system. These products are listed in the FDA’s UDI database, ensuring traceability and compliance with U.S. regulatory requirements.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Xinhua Healthcare Industry Co., Limited manufacture?
Xinhua Healthcare Industry Co., Limited specializes in orthopaedic tools for hip replacement surgery. Their primary focus is on acetabular orthopaedic devices, including acetabular bone rasps and an acetabular file connecting rod. These tools are specifically designed to prepare the pelvic bone during total hip arthroplasty procedures, ensuring proper placement of acetabular components.
Where is Xinhua Healthcare Industry Co., Limited based?
The company is based in the United States. While the exact location is not specified, their devices are regulated and listed under U.S. medical device compliance frameworks, such as the FDA’s Unique Device Identifier (UDI) system.
Which regulatory registries or databases list Xinhua Healthcare Industry Co., Limited’s devices?
Xinhua Healthcare Industry Co., Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance with U.S. regulatory requirements for medical devices, particularly for Class I devices like those produced by the company.
How are Xinhua Healthcare Industry Co., Limited’s devices classified under U.S. regulations?
The company’s devices fall under the classification of Class I medical devices. This classification is determined by the FDA based on the risk associated with the device’s use. Class I devices are generally considered low-risk and are subject to general controls, including the UDI system, to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 544386726
Catalogue (37)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Acetabular bone rasp | Cross 42 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 39 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 68 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 51 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 40 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 60 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 69 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 50 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 71 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 48 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 54 # | FDA UDI | Class I | Active |
| Acetabular file connecting rod | / | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 55 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 58 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 36 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 56 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 38 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 49 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 57 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 53 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 37 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 45 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 65 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 66 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 46 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 62 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 41 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 52 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 70 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 63 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 43 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 44 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 67 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 47 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 64 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 61 # | FDA UDI | Class I | Active |
| Acetabular bone rasp | Cross 59 # | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
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Authorities
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Xinhua Healthcare Industry Co., Limited Zibo Shandong · CN FEI 3013875765